The sponsor calls the site and informs the research team that they have decided to temporarily suspend the study. What step should the research team take FIRST?
A.
Schedule participant for early termination visit.
B.
Inform participant and assure proper care is provided.
C.
Inform the monitor of the termination of the study.
When a study is temporarily suspended, the primary responsibility of the research team is to ensure the ongoing care and safety of the enrolled participants. Participants must be informed about the suspension and assured that their health and safety will continue to be monitored.
GCP guidelines prioritize the safety and well-being of participants, which must be maintained even during a temporary suspension.
"In the event of a study suspension, the first priority is to inform the participants and ensure that appropriate care and monitoring are continued."
Objectives:
Protect participant safety during study suspension.
Maintain clear communication with study participants.
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